PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy
Study Details
Study Description
Brief Summary
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PEG-rhG-CSF patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy. |
Drug: PEG-rhG-CSF
Other Names:
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Outcome Measures
Primary Outcome Measures
- The occurrence rate of adverse event during at least three consecutive cycles chemotherapy [up to 30 days after the patient study completion]
- The severity of adverse event during at least three consecutive cycles chemotherapy [up to 30 days after the patient study completion]
Secondary Outcome Measures
- the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy [through the study completion,an average of 5 months]
- the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy [through the study completion,an average of 5 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with age ≥ 18 years
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diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer
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Karnofsky Performance Status ≥ 70
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life expectancy of at least 3 months
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Written informed consent are acquired
Exclusion Criteria:
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uncontrolled infection,Temperature is 38.0 ℃ or higher
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pregnancy
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Other situations that investigators consider as contra-indication for this study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPC-PGC-IV-01/CSPC-PGC-IV-02